Cobetter FluoroPV Filter Cartridges are made of hydrophilic polyvinylidene fluride (PVDF) membrane characterized by low extractable and protein binding. They are suitable for the sterilized filtration of pharmaceutical liquids such as ophthalmic liquids, biological and other diluted preservative solutions.

Features and Benefits

• Low extractable and protein binding

• Broad chemical compatibility and temperature resistance

• Great durability proven by testing forward/reverse pulse up to 100x

Quality Standards:

• Bacterial quantitative retention of 10⁷ CFU/cm² Brevundimonas Diminuta (ATCC 19146) according to ASTM F838 methodology .
• 100% Integrity testing in manufacturing .
• Each filter is fully traceable with serial number .

• Manufactured in a facility which adheres to ISO 9001: 2015 Practices .

• Full Regulatory Compliance with following :
  • Bacterial Endotoxin : Aqueous extraction of autocalved filter contains <0.25 EU/ml as determined by Limulus Amebcyte Lysate (LAL),USP<85>.

  • Non-fiber Releasing : Component materials meet the criteria for a "Non-fiber-releasing filter" as defined in 21 CFR 210.3(b)(6).

  • Component Material Toxicity :Meet the requirement of USP <87> In Vitro Cytotoxicity Test ; Meet the Criteria of USP<88> Biological Reactivity Test for Class VI-121℃ plastics

  • TOC/Conductivity at 25 ℃：Autoclaved filter effluent meet the USP<643> for Total Organic Carbon and USP<645> for

  • Water Conductivity per WFI requirements after a UPW flush of specified volume .

  • Particle Shedding : Autoclaved filter effluent meet the USP<788>for large volume Injections .

  • Indirect Food Additive：All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182 , and EU framework regulation [1935/2004/EC].
  
  
  

Typical Applications

• Antibiotics

• Aggressive Solvents

• Biologicals Agents

• Blood Products

• Cold and Hot WFI

• Chemicals

• Ophthalmic Solutions

• Sanitizing Agents